R3 Delta Ceramic Acetabular System
FDA premarket approval P150030/S003 · decided 2017-11-30
Approval details
- PMA number
- P150030
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- R3 Delta Ceramic Acetabular System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2017-08-17
- Decision date
- 2017-11-30
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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